K191580 is an FDA 510(k) clearance for the BRAVOS Afterloader System, Transfer Guide Tubes, Length Assessment Device. This device is classified as a System, Applicator, Radionuclide, Remote-controlled (Class II - Special Controls, product code JAQ).
Submitted by Varian Medical Systems, Inc. (Palo Alto, US). The FDA issued a Cleared decision on July 8, 2019, 24 days after receiving the submission on June 14, 2019.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.5700.
| 510(k) Number | K191580 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 14, 2019 |
| Decision Date | July 08, 2019 |
| Days to Decision | 24 days |
| Submission Type | Special |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | JAQ — System, Applicator, Radionuclide, Remote-controlled |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.5700 |